May 20, 2011

TB short course therapy, how long before approval?

No time at all if this is correct;
Rifapentine was approved in June 1998 as a treatment for pulmonary tuberculosis. It is the first new drug approved for tuberculosis in 25 years. It will be sold under the name Priftin and will be available in October 1998. The protocol for the trial is described. Rifapentine will be used in combination with existing therapies, and its safety and efficacy are similar to Rifampin. The Food and Drug Administration praised the manufacturer, Hoechst Marion Roussel, for conducting trials overseas and seeking accelerated approval. There is very little data related to the use of the rifapentine in HIV- positive patients.